DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 3, 2025 has been entered.
Status of the Claim
Claims 1, 3, 6-20 are pending. Claims 1, 3, 6 and 8 are under examination. Claims 7 and 9-20 are withdrawn. Any objections or rejections not repeated below have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 6 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 lines 1-2 recites, “A method for preparing an oligo-saccharide oat liquid composition as a milk substitute ingredient in a drink.” It is unclear if the claimed method is for 1) a method of preparing an oligo-saccharide oat liquid composition in a drink, or 2) a method for preparing an oligo-saccharide oat liquid composition where an intended use for the composition is a milk substitute ingredient in a drink. For the purpose of examination, the claimed method will be viewed as a method for preparing an oligo-saccharide oat liquid composition, where an intended use for the composition is a milk substitute ingredient in a drink.
Claims 3, 6 and 8 are rejected based on their dependence to a rejected base claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (USPreGrant Pub No. 2012/0034341), in view of Loponen et al. (WO 2020/025856) and GRAS Notice, GRN 1021, GRAS Panel Statement on the GRAS Status of Transglutaminase from Streptomyces mobaraensis (hereinafter, GRAS).
Regarding claim 1, Chen teaches a method for preparing an oligo-saccharide oat liquid composition (oat-based drink; Abstract, [0012]) as a milk substitute ingredient in a drink [0034]. Chen teaches the method comprises carrying out micro-milling (rolled oats are micronized with a mill to oat powder; [0020]).
Chen teaches the following milling step: (1) providing oats (rolled oats) as raw material, milling the raw material to form a micronized powder and dissolving or dispersing the micronized powder in an aqueous medium to form a raw material slurry (rolled oats are micronized by milling to form micronized oat powder that is blended in water to obtain an oat slurry; [0020]-[0021]). Chen discloses a milled oat average particle size of less than about 100 µm [0020], which is the same as the claimed range of micronized powder with an average particle size of less than about 100 µm. Chen discloses the raw material slurry (oat slurry) has a pH value of about 5, preferably about 5 to 8 (Claim 5; [0022]; [0036]). The prior art range is the same as the claimed range of a pH of about 5 to 8.
Chen teaches the micro-milled oats (micronized oats) are further subjected to a two-stage enzyme hydrolysis (two-stage enzymatic treatment; [0011], [0023]) to provide the oligo-saccharide oat liquid composition (oat-based functional drink; [0011]).
Chen teaches the following step for the first stage of enzyme hydrolysis: (2) in the first stage, adding beta-amylase to the raw material slurry to carry out a first-stage enzyme reaction until a viscosity of the oat slurry reaches a viscosity of about 1 to 0.1 Pas, preferably less than 0.3 Pas (Claim 1; [0023]; [0036]). This is within the claimed range of 0.5 to about 0.1 Pas.
Chen teaches trans-glucosidase, also spelled transglucosidase, is used in the second stage of the two-stage enzyme reaction and not in the first stage [0023]. However, Chen does state that as can be appreciated by persons of having ordinary skill that the enzymatic treatment will vary, along with many factors related to the enzymatic treatment, such as the enzyme added and other factors [0024]. Chen notes that the enzymatic treatments can be optimized based on the desired end product [0024].
It would have been obvious for one of ordinary skill in the art, before the effective filling date of the claimed invention, to have modified Chen by having the transglucosidase be used in the first stage of the enzyme reaction because the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) and MPEP 2144.04(IV). Additionally, Chen recognizes that the enzymatic treatment will vary, along with many factors related to the enzymatic treatment, such as the enzyme added and other factors [0024]. Chen notes that the enzymatic treatments can be optimized based on the desired end product [0024], this optimization would naturally extend to the order that enzymes are added.
Chen teaches the following step for the second stage of enzyme hydrolysis: (3) adding alpha-amylase to the first stage hydrolyzed raw material slurry (reaction mixture) to carry out a second-stage enzyme reaction (to proceed a further enzymatic reaction; [0023], [0036]). Chen discloses the second stage of enzymatic treatment is carried out until a viscosity of the oat slurry reaches a viscosity of about 0.1 to 0.01 Pas, preferably less than about 0.05 Pas (Claim 1; [0023]; [0036]). This is within the claimed range of about 0.05 to about 0.01 Pas.
Chen does not teach using transglutaminase enzyme in the second stage of the enzyme reaction.
Loponen teaches a method of preparing a liquid oat base suitable for human consumption with at least one enzymatic treatment ([0015]; Claim 1). Loponen discloses an aqueous oat raw material suspension that has a first enzymatic treatment with amylases ([0041]; Claim 5) and then undergoes a second enzymatic treatment with enzymes or a combination of enzymes, including protein modifying enzymes, in particular transglutaminase ([0041]; Claim 6). Loponen recognizes that subjecting oat raw material to at least one enzymatic treatment, including a second enzymatic treatment with transglutaminase, increases the solubility of oats, improves colloidal stability and obtains a high-protein liquid oat base [0012].
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Chen to incorporate the teachings of Loponen by adding transglutaminase to the second enzyme stage because subjecting oat raw material to at least one enzymatic treatment, including a second enzymatic treatment with transglutaminase, increases the solubility of oats, improves colloidal stability and obtains a high-protein liquid oat base, as recognized by Loponen [0012].
Chen teaches the method step of (4) heating the second-stage hydrolyzed raw material slurry to inactivate the enzymes (after the enzymatic treatments, the enzymes are inactivated with heating; [0026]), and then lowering the temperature (the mixture is cooled by lowering the temperature; [0026]).
Chen teaches the method step of (5) carrying out ultra-high temperature (UHT) instantaneous sterilization on the raw material slurry in step (4) to provide the oligo-saccharide oat liquid composition (after the inactivation and cooling, the reaction mixture is then subjected to Ultra High Temperature (UHT); [0027]).
Chen discloses the amounts of α-amylase, ß-amylase, and transglucosidase added for the enzymatic reactions are each about 0.1 to 1.0% (w/w) (Claim 7; [0025]), which is the same as the claimed range of α-amylase, ß-amylase, and transglucosidase, added each independently from about 0.1 to 1.0% (w/w).
Chen also discloses the operating temperature of the enzymatic reactions is about 40°C to about 70°C (Claim 7; [0025]), which is the same as the claimed range of operating temperature of the enzyme treatment at about 40°C to about 70°C.
As discussed above, Chen modified by Loponen also teaches the addition of transglutaminase as an enzyme added to the enzymatic treatment process. However, modified Chen does not teach an amount of transglutaminase added for the enzyme treatment.
GRAS teaches the safety and use of transglutaminase as a processing aid in food production [0001] including grain mixtures and vegetable protein products [0005]. GRAS discloses the maximum recommended use level of transglutaminase enzyme for various food categories, including grain mixtures and vegetable protein products, to be 0.05-1.0% enzyme concentration added for enzyme treatment (pg. 16 Table A-1). It is noted that oats are recognized as a grain. The prior art range fully encompasses the claimed range of 0.1 to 1.0% (w/w) transglutaminase added for enzyme treatment.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Chen in view of Loponen by incorporating the teachings of GRAS, to have selected the transglutaminase within the range taught by GRAS and within the claimed range for transglutaminase because adding transglutaminase within the claimed range would provide a product having intramolecular or intermolecular crosslinking of proteins, as recognized by GRAS [0005].
Chen in view of Loponen and GRAS teaches a substantially identical method of preparing an oligo-saccharide oat liquid composition, as shown by the above rejection. Since the composition of modified Chen is substantially identical to the claimed composition it is considered to possess the property of providing a good emulsifying capacity to a drink comprising the oligo-saccharide oat liquid composition as a milk substitute ingredient, and the good emulsifying capacity is defined by no marbling or separation of layers occurring after 90 minutes of standing of the drink, absent convincing arguments or evidence to the contrary. Thus, the oligo-saccharide oat liquid composition of modified Chen is considered to have the emulsifying effects as claimed. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Regarding claim 3, Chen teaches the aqueous medium in step (1) comprises deionized water (the micronized oat powder is blended with water, specifically deionized water; [0019], [0022]).
Regarding claim 6, Chen teaches step (6): packaging the oligo-saccharide oat liquid composition by an aseptic cool filling system (after UHT processing to inactivate enzymes, the oat-based drink can be packed in an aseptic cool filling system; Claim 9, [0027]).
Regarding claim 8, modified Chen teaches step (a) a method for preparing an oligo-saccharide oat liquid composition according to the method outlined in the rejection of claim 1 above.
Regarding step (b), Chen teaches processing the oligo-saccharide oat liquid composition prepared in step (a) by a drying process to prepare the oligo-saccharide oat powder composition (dehydrating and drying, using drying such as spray-drying, the resultant micronized oat-based drink, to form a stable oat-based drink powder; [0027] (Claim 7).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 6 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, and 8-9 of U.S. Patent No. 8,337,880 (cited on IDS received 04/21/2022; herein referred to as ‘880; granted patent version of “Chen” referenced above), and in view of Loponen et al. (WO 2020/025856), and GRAS Notice, GRN 1021, GRAS Panel Statement on the GRAS Status of Transglutaminase from Streptomyces mobaraensis, (hereinafter GRAS). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim limitations are made obvious by claims 1-2, 4-6, and 8-9 of ‘880 in view of Loponen and GRAS.
Independent claim 1 of the examined application recites, “A method for preparing an oligo-saccharide oat liquid composition as a milk substitute ingredient in a drink, the method comprising carrying out micro-milling and two-stage enzyme hydrolysis on an oat raw material to provide the oligo-saccharide oat liquid composition, wherein ß-amylase and transglucosidase are used in the first stage, and α-amylase and transglutaminase are used in the second stage.”
Claim 1 of the conflicting patent ‘880 recites “A method for producing an oligo-saccharide enhanced oat-based drink.” It is noted that the recitation, “as a milk substitute ingredient in a drink” does not further limit the claim. Said recitation is merely directed at the intended use of the claimed oligo-saccharide oat liquid composition.
Claim 1 of the conflicting patent teaches an oligo-saccharide enhanced oat-based drink which comprises “Providing an oat slurry of micronized oat powders”. The slurry then has a two-stage enzyme hydrolysis by treating “with ß-amylase” and then “with α-amylase and transglucosidase” which provides “a stable oligo-saccharide enhanced oat-based drink.” Claim 2 of the conflicting patent recites the slurry used in claim 1 is “obtained by dry milling rolled oats to oat powders” and later in the same claim refers to the oat powders as “micronized oat powders.”
Thus, the conflicting patent ‘880, claims 1 and 2, read on a method for preparing an oligo-saccharide oat liquid composition, comprising dry rolled oats, which are considered an oat raw material, that have been micronized through dry milling, and a two-stage enzyme hydrolysis carried out on the on the slurry obtained through dry milling the rolled oats, resulting in an oligo-saccharide oat liquid. The first stage of the enzyme hydrolysis is treating with ß-amylase, and the second stage treating the slurry with α-amylase and transglucosidase.
Claims 1-2 of the conflicting patent ‘880, do not require transglucosidase being used in the first stage of enzyme hydrolysis and does not teach transglutaminase being used in the second stage.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used the transglucosidase in the second stage of enzyme hydrolysis as found in the conflicting patent ‘880, in the first stage of enzyme hydrolysis with ß-amylase because a prima facie case of obviousness exists for a change in sequence of adding ingredients. One of ordinary skill in the art before the effective filing date of the invention would have expected a change in sequence or change in order of preforming process steps, to have the same properties in the absence of new or unexpected results. MPEP 2144.04, in part, states:
Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
Regarding the conflicting patent ‘880 not using transglutaminase, Loponen teaches a method of preparing a liquid oat base suitable for human consumption with at least one enzymatic treatment ([0015]; Claim 1). An aqueous oat raw material suspension undergoes a first enzymatic treatment with amylases ([0041]; Claim 5) and then undergoes a second enzymatic treatment with enzymes or a combination of enzymes, including protein modifying enzymes, in particular transglutaminase ([0041]; Claim 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the conflicting patent ‘880, in view of Loponen, to add the additional enzyme transglutaminase to the second enzyme stage because subjecting oat raw material to at least one enzymatic treatment, including a second enzymatic treatment with transglutaminase, increases the solubility of oats, improves colloidal stability and obtains a high-protein liquid oat base, as recognized by Loponen [0012].
Amended claim 1 of the examined application requires the following steps: (1) providing oats as a raw material, milling the raw material to form micronized powder with an average particle size of less than about 100 µm, and dissolving or dispersing the micronized powder in an aqueous medium to form a raw material slurry, and the raw material slurry has a pH of about 5 to 8;(2) in the first stage, adding beta-amylase and transglucosidase to the raw material slurry to carry out a first- stage enzyme reaction until a viscosity of the raw material slurry reaches about 0.5 to about 0.1 Pas, thereby obtaining a first-stage hydrolyzed raw material slurry;(3) in the second stage, adding alpha-amylase and transglutaminase to the first-stage hydrolyzed raw material slurry to carry out a second-stage enzyme reaction until a viscosity of the raw material slurry reaches about 0.05 to about 0.01 Pas, thereby obtaining a second-stage hydrolyzed raw material slurry;(4) heating the second-stage hydrolyzed raw material slurry to inactivate the enzymes, and then lowering the temperature; and(5) carrying out ultra-high temperature (UHT) instantaneous sterilization on the raw material slurry in step (4) to provide the oligo-saccharide oat liquid composition.
Wherein amounts of alpha-amylase, the beta-amylase, the transglucosidase and the transglutaminase added each independently ranges from about 0.1 to 1.0% (w/w), and an operating temperature of the enzyme treatment is about 40°C to about 70°C; Wherein the oligo-saccharide oat liquid composition provides good emulsifying capacity to a drink comprising the oligo-saccharide oat liquid composition as a milk substitute ingredient, and the good emulsifying capacity is defined by no marbling or separation of layers occurs after 90 minutes of standing of the drink.
Claim 2 of ‘880 recites, “milling rolled oats to oat powders”, which provides oats as a raw material. Claim 1 requires, step (1) “Providing an oat slurry of micronized oat powders having an average particle size of less than about 100 µm”. Claim 2 requires the oat slurry used in step (1) of claim 1 is obtained by “blending the oat powders with water” which is dispersing the micronized powder in an aqueous medium to form a raw material slurry. Claim 5 of ‘880 recites “the oat slurry used in step (1)” of claim 1, “has a pH value of at least about 5 to 8.” The pH range of ‘880 is the same as the claimed range of the examined application of at least about 5 to 8.
Step (2) in claim 1 of the conflicting patent ‘880, recites, “treating the oat slurry with ß-amylase to a viscosity of about 0.3 to 0.1 Pas”, which is carrying out a first-stage enzyme reaction until a viscosity of the raw material slurry is reached. The viscosity of ‘880 falls completely within the claimed range of the examined application of 0.5 to about 0.1 Pas.
Step (2) in claim 1 of ‘880 continues by reciting, “and with α-amylase and transglucosidase to a viscosity of 0.05 to 0.01 Pas”, which is adding enzymes to the first-stage hydrolyzed raw material slurry to carry out a second-stage enzyme reaction, thereby obtaining a second-stage hydrolyzed raw material slurry. The viscosity of ‘880 is the same as the claimed range of the examined application of about 0.05 to about 0.01 Pas.
Step (3) in claim 1 of ‘880 recites, “Inactivating the enzymes with heating, and then cooling the reaction mixture” which is heating the second-stage hydrolyzed raw material slurry to inactive the enzymes, and then lowering the temperature.
Step (4) in claim 1 of ‘880 recites, “Subjecting the reaction mixture to Ultra High Temperature (UHT) to provide a stable oligo-saccharide enhanced oat-based drink”, which is carrying out instantaneous sterilization on the raw material slurry in the previous step to provide the oligo-saccharide oat liquid composition.
As noted in the above rejection, it would have been obvious to have used the transglucosidase in the second stage of enzyme hydrolysis as found in ‘880, in the first stage of enzyme hydrolysis since a prima facie case of obviousness exists for a change in sequence of adding ingredients. See MPEP 2144.04, Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959).
Further, as noted in the above rejection, it would have been obvious to have added the additional enzyme transglutaminase to the second enzyme stage.
Thus, claim 1 of the examined application is made obvious by claims 1-2 of ‘880 in view of Loponen and teaches steps (1) through (5) of newly amended claim 1 of the examined application.
Claim 6 of ‘880, recites “amounts of α-amylase, ß-amylase, and transglucosidase used in step (2)” of claim 1, “are each about 0.1 to 1.0% (w/w) and the enzymatic treatments are operated at the temperature of about 40 to about 70°C.” The enzyme amount ranges and range of operating temperature of ‘880 is the same as the claimed range of the examined application; specifically the claimed application range of α-amylase, ß-amylase, and transglucosidase at about 0.1 to 1.0% (w/w), and the claimed application range of operating temperature of the enzyme treatment at about 40°C to about 70°C.
As discussed above, ‘880 modified by Loponen also teaches the addition of transglutaminase as an enzyme added to the enzymatic treatment process. However, modified ‘880 does not teach an amount of transglutaminase added for the enzyme treatment.
GRAS teaches the safety and use of transglutaminase as a processing aid in food production [0001] including grain mixtures and vegetable protein products [0005]. GRAS discloses the maximum recommended use level of transglutaminase enzyme for various food categories, including grain mixtures and vegetable protein products, to be 0.05-1.0% enzyme concentration added for enzyme treatment (pg. 16 Table A-1). It is noted that oats are recognized as a grain. The prior art range fully encompasses the claimed range of 0.1 to 1.0% (w/w) transglutaminase added for enzyme treatment.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified ‘880 in view of Loponen to have incorporated the teachings of GRAS, to have selected the transglutaminase within the claimed range because adding transglutaminase would provide a product having intramolecular or intermolecular crosslinking of proteins, as recognized by GRAS [0005].
Regarding the last wherein clause of the examined application, conflicting patent ‘880 in view of Loponen and GRAS teaches a substantially identical method of preparing an oligo-saccharide oat liquid composition, as shown by the above rejection. Since the composition of ‘880 in view of Loponen and GRAS is substantially identical to the claimed composition it is considered to possess the property of providing a good emulsifying capacity to a drink comprising the oligo-saccharide oat liquid composition as a milk substitute ingredient, and the good emulsifying capacity is defined by no marbling or separation of layers occurring after 90 minutes of standing of the drink, absent convincing arguments or evidence to the contrary. Thus, the oligo-saccharide oat liquid composition of modified ‘880 is considered to have the emulsifying effects as claimed. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Therefore, claim 1 of the examined application is made obvious by claims 1, 2, 5 and 6 of ‘880 in view of Loponen and in further view of GRAS.
Claim 3, of the examined application, requires the aqueous medium in step (1) to comprise deionized water.
Claim 4 of ‘880, recites “the oat slurry used in step (1)” of claim 1, “is prepared with de-ionized water”, which is an aqueous medium. Thus, claim 3 of the examined application is made obvious by claim 4 of ‘880.
Claim 6, of the examined application, requires a step (6): packaging the oligo-saccharide oat liquid composition by an aseptic cool filling system.
Claim 8 of ‘880, Chen recites “further comprising the step of packing the micronized oat-based drink obtained in step (4)” of claim 1, “in an aseptic cool filling system.” Thus, claim 6 of the examined application is made obvious by claim 8 of ‘880.
Claim 8, of the examined application, requires the following steps (a) preparing an oligo-saccharide oat liquid composition by the method according to claim 1, and (b) processing the oligo-saccharide oat liquid composition prepared in step (a) by a drying process to prepare the oligo-saccharide oat powder composition.
Claim 9 of ‘880, Chen modified by Loponen, recites “the method of claim 1, further comprising the step of dehydrating the micronized oat-based drink obtained in step (4) to obtain micronized oat-based powders.” Thus, claim 8 of the examined application is made obvious by claim 9 of ‘880.
Response to Argument
Applicant's arguments filed July 3, 2025 have been fully considered but they are not persuasive.
Unexpected effects of the invention.
Applicant argues, on pgs. 7-8 of their remarks, that current claim 1 now recites the improved properties and features of the invention. Applicant states the features are oat compositions and drinks which have better liquid uniformity, foaming capacity, stability and emulsifying capacity, contain rich functional ingredients such as beta-glucan and isomaltooligosaccharide and have the effect of enhancing immunity. However, the Office disagrees for the following reasons.
As shown in the amended claims, the only feature now claimed out of the list of features is emulsifying capacity. The rest of the features are still not recited in claim 1 and the rest of the features upon which applicant relies (i.e., oat compositions and drinks which have better liquid uniformity, foaming capacity, stability, contain rich functional ingredients such as β-glucan and isomaltooligosaccharide and have the effect of enhancing immunity) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Additionally, the feature of emulsifying capacity is considered a property of the oligo-saccharide oat liquid composition. Therefore, since the composition of modified Chen is substantially identical to the claimed composition it is considered to possess the property of providing a good emulsifying capacity to a drink comprising the oligo-saccharide oat liquid composition as a milk substitute ingredient. Thus, the oligo-saccharide oat liquid composition of modified Chen is considered to have the emulsifying effects as claimed. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Applicant argues, on pgs. 7-8 of their remarks, that the improved properties have been evidenced to be directly related to the specific sequence and combination of enzymes used in the two-stage hydrolysis. Applicant states that the sequence of addition and types of enzymes significantly affect the properties of the oat liquid composition used as a milk substitute for a (latte) drink, noting Point 8 of Declaration submitted 02/23/2024. Applicant continues stating the specific sequence and combination of enzymes are the limitations providing the improved properties and that the experiments were carefully designed and the standards were meaningful, resulting in unexpected results. Applicant discusses specific results of their experiment of the 5 tests they conducted, see Table B pg. 2 of Declaration dated 02/23/2024. Applicant states that the specific sequence and combination of enzymes used in the two-stage hydrolysis would not naturally flow to the desired effect exhibited by the claimed invention. However, the Office disagrees for the following reasons.
For unexpected results over a claimed range and unexpected results for sequence order of adding the enzymes, a sufficient number of tests that are commensurate with the scope of the claims both inside and outside the claimed parameters must be completed to show the criticality of the claimed parameters. See MPEP 716.02(d). As shown in independent claim 1, when the oat liquid composition is prepared can any amount of the enzymes β-amylase, transglucosidase, α-amylase and transglutaminase be added to achieve the desired unexpected results inside the range given of 0.1 to 1.0% (w/w)? For example, can these enzymes be added in preparation of the oat liquid composition at 0.1%, or 0.5% or 1% and achieve the same unexpected results? This same concept applies to other parameters such as the pH and operating temperature of the enzyme treatment. Can the method of claim 1 be carried out at any pH within the claimed range or at any temperature within the claimed range and still achieve the desired unexpected results? Also, only 5 enzyme sequence additions were looked at in the declaration, see Table A pg. 2 of Declaration. Would an enzyme sequence addition of beta-amylase in the first stage and alpha-amylase, transglutaminase, and transglucosidase, not achieve the unexpected results? Would an enzyme sequence where alpha-amylase and transglucosidase are used in the first stage and beta-amylase and transglutaminase are used in the second stage not achieve the unexpected results? The Applicant has not provided any data regarding these parameters and if these ranges within these parameters will still achieve the unexpected results.
Additionally, there are only so many iterations that four enzymes can be added when there are two stages for the enzyme addition, so it would not be unreasonable for a person of ordinary skill in the art to test all the different iterations of enzyme addition, as it would be routine experimentation. Therefore, the type of enzyme and the addition of that enzyme in the first stage or second stage can be adjusted to meet the needs at hand and are result-effective variables. Chen discusses this stating that as can be appreciated by persons of having ordinary skill that the enzymatic treatment will vary, along with many factors related to the enzymatic treatment, such as the enzyme added and other factors [0024]. Chen notes that the enzymatic treatments can be optimized based on the desired end product [0024], such as an end product with improved colloidal stability, as recognized by Loponen [0012]. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, the claimed sequence and combination of enzymes used in the two-stage hydrolysis would naturally flow from following the suggestions of the prior art and is made obvious over the cited references.
Non-obviousness of transglucosidase being used in the first stage of enzyme hydrolysis.
Applicant argues, on pg. 9 of their remarks, that Chen, Loponen, Health Canada and Lee do not disclose, teach or suggest using transglucosidase in the first enzymatic stage and that the references are insufficient to support the conclusion that a change in the sequence of adding enzymes would be obvious for a skilled person in the art. However, the Office disagrees for the following reasons.
Regarding Health Canada and Lee, these evidentiary references have been removed from the rejection. Thus, these arguments are moot because the rejection no longer relies on these evidentiary references.
Regarding Chen and Loponen references being insufficient to support the conclusion that a change in sequence of adding enzymes would not be obvious for a skill person in the art, Chen states that as can be appreciated by persons of having ordinary skill that the enzymatic treatment will vary, along with many factors related to the enzymatic treatment, such as the enzyme added and other factors [0024]. Chen notes that the enzymatic treatments can be optimized based on the desired end product [0024]. One factor that relates to the enzymatic treatment is the order of enzyme addition, such as adding transglucosidase in the first stage of enzyme hydrolysis instead of the second stage. Therefore, the rejection provided above of Chen in view of Loponen and GRAS does support the conclusion that a change in the sequence of adding enzymes would be obvious for a skilled person in the art. See MPEP 2144.04(IV).
Non-obviousness of transglutaminase being used in the second stage.
Applicant argues, on pgs. 10-11 of their remarks, that the Loponen reference focuses on ultrasonication method instead of enzyme addition and sequence to prepare liquid oat base composition. Applicant states that Loponen focuses on the ultrasonication method and the attributes of improved solubility and stability are attributed solely to the ultrasonication. Additionally, Applicant argues that Loponen does not provide any information or characteristics regarding the non-ultrasonicated, enzymatically treated oat protein concentrate. Applicant concludes that Loponen fails to teach the present invention’s biochemical pathway of achieving functional improvements through a deliberately sequenced, dual-stage enzymatic treatment without physical aid such as ultrasonication. However, the Office disagrees for the following reasons.
As discussed in the above rejection, Loponen does teach an aqueous oat raw material suspension undergoes a first enzymatic treatment with amylases ([0041]; Claim 5) and then undergoes a second enzymatic treatment with enzymes or a combination of enzymes, including protein modifying enzymes, in particular transglutaminase ([0041]; Claim 6). Loponen also recognizes that a combination of at least one enzymatic treatment on the oat raw material improves colloidal stability [0012], [0023], [0041]. While the Loponen reference does teach ultrasonication as part of the method steps, the addition of enzymes is also important and contributes to the colloidal stability of the oat suspension, otherwise it would not be in the disclosure or claimed by Loponen.
Regarding the argument that Loponen fails to teach the present inventions biochemical pathway of achieving the claimed product, while Loponen do not disclose all the features of the present claimed invention, Loponen is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely, the use of transglutaminase in the second stage of enzymatic treatment and in combination with the primary reference, discloses the presently claimed invention. Additionally, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Thus, the secondary reference of Loponen would have suggested that the use of transglutaminase as an enzyme to be added to the second stage of an enzymatic treatment sequence would help improve the colloidal stability of the oat solution ([0041]; Claim 6).
Double Patenting Rejection
Applicant argues the double patenting rejection, on pgs. 11-12 of their remarks, stating the subject application is patentably distinct for at least the reasons of non-obviousness of the invention as discussed in their arguments. However, the Office disagrees.
As outlined above the Office disagrees with the Applicant’s arguments of non-obviousness of the invention. Therefore, the double patenting rejection is maintained.
Conclusion
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/S.R.G./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791